Overview
Sponsor-declared trial summary
Phase
Human pharmacology (Phase I) - Bioequivalence study
Status
Authorised, recruitment pending
Participants planned
72
Countries
1
Sites
1
Adjuvant treatment of BRAF V600E or V600K mutation-positive melanoma (in combination with dabrafenib);
Key facts
- Sponsor
- Sun Pharmaceutical Industries Limited
- Participant type
- Healthy volunteers
- Age range
- 18-64 years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Neoplasms [C04]
- Decision date (initial)
- 2026-04-30
- Transition trial
- No
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- No
Trial design
CTIS Part I — objectives, methods, condition coding
Conditions and MedDRA coding
Adjuvant treatment of BRAF V600E or V600K mutation-positive melanoma (in combination with dabrafenib);
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Sun Pharmaceutical Industries Limited
- Sponsor organisation
- Sun Pharmaceutical Industries Limited
- Address
- Sun House Plot No 201 B/1, Western Express Highway, Goregaon East Western Express Highway Goregaon East
- City
- Mumbai
- Postcode
- 400063
- Country
- India
Scientific contact point
- Organisation
- Sun Pharmaceutical Industries Limited
- Contact name
- Arshad Khuroo
Public contact point
- Organisation
- Sun Pharmaceutical Industries Limited
- Contact name
- Arshad Khuroo
Locations
1 EU/EEA country · 1 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Romania | Authorised, recruitment pending | 72 | 1 |
| Rest of world | — | 0 | — |
Investigational sites
Terapia S.A.
Clinical Pharmacology and Pharmacokinetics, Strada Fabricii Nr. 124, 400640, Cluj-Napoca
Application history
1 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2026-01-19 | Romania | No conclusion 2026-04-21
|
2026-04-30 |